BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON-PRATT 10 FR

    MDR report key: 1665461 · Received April 21, 2010

    Report

    Report Number
    1665461
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 21, 2010
    Manufacturer
    MEDLINE
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD 2 JP DRAINS AT THE SURGICAL SITE. ONE WAS REMOVED WITHOUT INCIDENT, WHILE THE SECOND DRAIN MET RESISTANCE UPON REMOVAL. AFTER MULTIPLE REMOVAL ATTEMPTS AND MANIPULATIONS, THE TUBING BROKE SO THAT THE END WAS NOT VISIBLE. A CT SCAN CONFIRMED A RETAINED PIECE AND THE PATIENT WAS RETURNED TO THE OR FOR REMOVAL - NO PATIENT ISSUES. THE PATIENT IS DISCHARGED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON-PRATT 10 FR WOUND DRAIN GCY MEDLINE DYNJWE0321 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR NO OTHER THERAPIES